2018 Section 6 - Laryngology, Voice Disorders, and Bronchoesophalogy

Ann Thorac Surg 2017;103:246 – 53

SHADMEHR ET AL

SYSTEMIC STEROIDS IN TRACHEAL STENOSIS

surgery for a precise evaluation of the characteristics and length of the stenosis, aspiration of secretions, core-out of granulation tissues, and dilation of the stenotic segments as required. This procedure is transiently helpful for most of these patients. It may also be curative in some patients; however, for the majority, especially patients who already have established fi brosis and cartilage destruction, one or even several times of dilation would not be effective, and airway resection and reconstruction would fi nally be required, if feasible. Even if airway resection is indicated at the time of the fi rst presentation, many of these patients are not in an ideal situation for surgical resection, because of the concomitant laryngeal injuries, laryngotracheal edema, infection, granulation tissue formation, and mucositis, as well as associated other organs injury or comorbid diseases [4] . In this very usual situation, the airway of patients should be temporarily kept open by repeated bronchoscopic dilation (RBD), while the coexisting prob- lems are fi xed or appropriately managed. During 20 years of concentrated work with these patients, we learned that whereas most of them pass the required interval to be prepared for a de fi nitive airway resection, eventually, some of them suf fi ciently recover by RBD, antibiotics, airway toilet, and humidi fi cation. These RBD require frequent hospital admissions and general anesthesia, which is a signi fi cant physical, psy- chological, and economic burden for these patients and the health system. To fi nd a way to decrease this stress, a question came to our mind that, based on our best knowledge, has never been answered in the literature. The question was whether systemic corticosteroid adminis- tration (because of the in fl ammatory nature of PITS) could be bene fi cial for this group of patients in this period, in one or some of these ways: (1) increase the interval between the required bronchoscopic procedures; (2) decrease the number of patients who would eventually need airway resection; and (3) shorten the length of tra- chea needing resection. To answer these hypotheses, a randomized double-blind clinical trial was designed in our hospital. Patients and Methods This patients and surgeons blinded parallel study was a single-center trial carried out at our center. The study was approved by the Institutional Research and Ethics Com- mittees (C-87-778 December 2008) and registered at the Iranian Registry of Clinical Trial website ( www.irct.ir , IRCT2014103019760N1). Patient Selection, Randomization, and Blinding From February 2009 until November 2012, 522 patients with PITS were admitted to our thoracic surgery ward, and their data were prospectively entered in our original database for all tracheal diseases (Alborz Database). Of them, 402 met one or some of the exclusion criteria ( Table 1 ) or had at least one corticosteroid consumption contraindication ( Table 2 ). The remaining 120 eligible patients were enrolled in this study and randomized to

either the study group (corticosteroids [group C]) or the control group (placebo group [group P]). After the fi rst bronchoscopy by us, and if indicated, the randomization was performed by our ward general practitioner physi- cian, who had no role in the diagnosis and management of the patients. The surgeons and the patients were un- aware of the groups. At bronchoscopy, the data, including length and diameter of stenosis, nature of stenosis, its distance from vocal cords and carina, presence of granulation tissue, edema and infection, as well as anatomy and function of the vocal cords and supraglottic larynx, were precisely evaluated and documented. Then, therapeutic aspiration of secretions, core-out of granulation tissues, and dilation of the stenosis with increasingly larger sized rigid bron- choscopes were performed. After a full recovery, all potential hazards of cortico- steroids (even if the dosage is low) were explained to the patients along with its possible bene fi ts. After taking the patients ’ informed consent (those under age 18 years also required consent by their parents), they were assigned one by one to each group alternatively: odd numbered arrivals were assigned to group C, and even numbered arrivals to group P. Intervention Based on our hospital (as a referral center) protocol for management of patients with PITS, all patients under- went RBD, airway toilet, humidi fi cation, and antibiotics administration (if indicated and based on the result of culture), until their respiratory status stabilized or they stable with no other anticipated surgical procedure Patients with recurrent stenosis after airway resection Patients younger than 15 years No patient consent No corticosteroid compliance or corticosteroid contraindications ( Table 2 ) Any patient receiving corticosteroid treatment at the beginning of study for other reasons, such as myasthenia gravis Table 2. Corticosteroid Treatment Contraindications Severe cardiovascular diseases (such as congestive heart failure) Severe/uncontrolled hypertension Severe/uncontrolled diabetes mellitus Morbid obesity History of tuberculosis Active acid-peptic disease History of psychosis Glaucoma Table 1. Exclusion Criteria Patients who presented with tracheostomy or T tube Patients for whom, at presentation, more than 6 months had been passed since intubation Patients fi t for airway resection at presentation (pure malatic stenosis or stenosis with matured fi brosis without edema, infection, or granulation tissue), who were also medically

GENERAL THORACIC

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